PMDA device listing

フレキシブルアーム

PMDA Medical device listing · 11B1X00016000235 · Class I

Key facts

PMDA document key 380082_11B1X00016000235_A_01
Brand names フレキシブルアーム
General names (JMDN) 手術台アクセサリー
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 11B1X00016000235
JMDN codes 70469000
Category code A0100
Marketing authorization holder 製造販売/泉工医科工業株式会社
Package insert date Jan 31, 2018
Latest revision 2016-12
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • None Related PMDA documents
  • Listed Listed on the PMDA site
  • No Refers to a technical manual

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA medical device and IVD listings (Japan)

Medical devices and in vitro diagnostics sold in Japan are approved by the MHLW, certified by a registered certification body or notified, depending on class, and the PMDA publishes each product's package insert. Only identifiers, names and dates are shown here; package insert text and review reports are not reproduced.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, medical device package insert database · Source date:

Browse all PMDA medical device and IVD listings (Japan)